Apparatus for removing an elongated structure implanted in biological tissue

ABSTRACT

Heart lead removal apparatus for removing an implanted cardiac pacemaker lead from the wall of a heart through a blood vessel leading to the heart. The lead removal apparatus comprises an outer tube sized for insertion into the coiled structure passageway of the pacemaker lead; an anchoring projection positioned proximate the distal end of the outer tube; and a stylet positioned through the passageway of the outer tube for urging the anchoring projection between relaxed and hooked positions. In the hooked position, the projection extends outwardly from the outer tube and when also positioned in the coiled structure passageway, hooks into the coiled structure for facilitating removal of the lead from the heart. In the relaxed position, the anchoring projection is insertable into the coiled structure passageway. In other aspects of the lead removal apparatus, the expandable means of the apparatus includes a barb positioned about the distal end of the outer tube; a slotted sleeve positioned between the distal ends of the outer tube and an actuator rod; and an expandable pliable plastic sleeve positioned between the pliable tube and the actuator rod.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of application Ser. No. 07/691,706,filed Apr. 26, 1991, now U.S. Pat. No. 5,207,683, entitled "Apparatusfor Removing an Elongated Structure Implanted in Biological Tissue",which is a continuation-in-part of application Ser. No. 07/363,960,filed Jun. 9, 1989, now U.S. Pat. No. 4,943,289, entitled "Apparatus forRemoving an Elongated Structure Implanted in Biological Tissue", whichis a continuation-in-part of application Ser. No. 07/347,217, filed May3, 1989, now U.S. Pat. No. 5,011,482, entitled "Apparatus for Removingan Elongated Structure in Biological Tissue", which is acontinuation-in-part of application Ser. No. 07/298,100, filed Jan. 17,1989, now U.S. Pat. No. 5,013,310, entitled "Method and Apparatus forRemoving an Implanted Pacemaker Lead", which is a continuation-in-partof application Ser. No. 07/269,771, filed Nov. 9, 1988, now U.S. Pat.No. 4,988,347, entitled "Method and Apparatus for Separating a CoiledStructure from Biological Tissue".

TECHNICAL FIELD

This invention relates to elongated structures, such as a catheterimplanted in tissue or an electrical pacemaker lead implanted in theheart and, particularly, to apparatus for removing such elongatedstructures implanted in biological tissue.

BACKGROUND OF THE INVENTION

A heart pacemaker is generally implanted subcutaneously in the chestwall along with a coiled structure such as an electrical wire coil leadfor conducting electrical signals such as stimulating and sensingsignals between the pacemaker and the heart. The lead is surgicallyimplanted through a vein leading to a cavity of the heart. A typicallead includes one or more helical wire coils having a hollow innerpassageway that extends the entire length of the wire coil. The coiledstructures are positioned in the lead either coaxially or laterally. Thewire coils are surrounded by an insulating material such as a flexibletube, sheath, or coating comprising, for example, silicone orpolyurethane for insulating the wire coils from body fluids as well aseach other. However, one problem is that, over time, fibrotic tissuecommonly encapsulates the pacemaker lead especially in areas where thereis low velocity blood flow. When small diameter veins through which thelead passes become occluded with fibrotic tissue, separating the leadfrom the vein is difficult and causes severe damage or destruction ofthe vein. Furthermore, the separation is usually not possible withoutrestricting or containing the movement of the pacemaker lead.

In most cases, the useful life of a pacemaker lead lasts for many years.However, should the pacemaker lead become inoperative or should anotherheart lead be desired, the existing pacemaker lead is typically left inplace, and a new pacemaker lead is implanted. One problem with leavingan implanted lead in place, particularly in the heart, is that the leadactually restricts the operation of the various heart valves throughwhich the lead passes. If several leads passing through a heart valveare left in place, the operation of the heart valve and the efficacy ofthe heart is significantly impaired.

Another problem associated with leaving a pacemaker lead in place,particularly in blood vessels, is that an infection may develop in oraround the lead, thereby requiring surgical removal. Surgical removal ofthe lead from the heart often involves open heart surgery withaccompanying complications, risks, and significant cost.

One method for transvenous removal of a pacemaker lead involves a priorart heart lead removal tool that utilizes a hollow, rigid tube and abeveled rod tip for engaging and deforming the coiled structure of theheart lead. However, when the lead cannot be removed because of somecomplication, a serious problem is that the tip of the tool is locked inplace and cannot be removed from the lead. As a result, the tool andlead must be surgically removed. Furthermore, the rigid tube of the toolcan easily puncture a blood vessel or, even worse, a heart cavity wall.

Another method is to transvenously extract the lead manually without theaid of a tool. Such method is possible only when the lead has not beenencapsulated in or restricted by a blood vessel. Even then, this methodhas a number of problems. First, when the polyurethane or siliconinsulation surrounding the wire coil is damaged, the insulation cansever and cause the coiled structure of the lead to unwind and possiblyto damage the heart and surrounding blood vessels. Secondly, when boththe coiled structure and insulation are severed in the heart or a bloodvessel, surgical removal is required. Thirdly, most pacemaker leadstypically include tines or a corkscrew at the tip or a conically shapedtip for securing the distal end of the pacemaker lead to a heart cavitywall. For fibrotic tissue that has encapsulated the tip, unaided manualremoval of the heart lead from the heart cavity wall may cause an inwardextension or inversion of the wall, or even worse, permanent damage tothe heart such as tearing a hole in the heart cavity wall.

The flexible stylet wire of the lead removal apparatus as described inthe cross-referenced related applications is particularly well-suitedfor the removal of a pacemaker lead implanted in the heart andencapsulated in vessels connecting with the heart. However, engaging andsecuring the coiled structure at the far-most distal end of the leadwith the expandable wire coil of the stylet wire can present a problem.When radially expanding the wire coil, the distal end of the stylet wirecan recede from the electrode at the far-most distal end of thepacemaker lead. This can occur prior to the wire coil securing thestylet wire to the pacemaker lead. Consequently, the pacemaker lead canbe severed during the extraction procedure, thus leaving the electrodeand a small distal portion of the lead remaining in the heart tissue.The removal of the severed electrode would thus require a further timeconsuming and complicated intravascular or open-heart surgicalprocedure.

SUMMARY OF THE INVENTION

The foregoing problems are solved and a technical advance is achievedwith illustrative lead removal apparatus for removing an implanted,cardiac pacemaker lead. The pacemaker lead includes, as previouslysuggested, a coiled structure such as an electrical wire coil forconducting electrical signals between the pacemaker and the heart. Thiscoiled structure typically has a hollow inner passageway that extendslongitudinally therethrough. The wire coil is surrounded by insulatingmaterial for insulating the wires from body fluids. The lead removalapparatus includes control means having a distal end for insertion intothe passageway of the coiled structure. The lead removal apparatus alsoincludes expandable means positioned proximate the distal end of thecontrol means. The expandable means also has an expanded position in thecoiled structure passageway for securing the control means to the coiledstructure for removal of the implanted lead from the heart.

In one aspect, the control means comprises actuator means for expandingthe expandable means to the expanded position when the expandable meansis positioned in the passageway of the coiled structure. The expandablemeans also includes a relaxed position for positioning the lead removalapparatus in the coiled structure passageway.

In another aspect, the control means includes an outer tube and anactuator rod insertable through the outer tube. The expandable meansincludes a barb positioned proximate the distal end of the outer tube.When the actuator rod is positioned proximate the distal end of theouter tube, the rod expands the barb to the expanded position.

In another aspect, the expandable means includes a slotted sleevepositioned between the distal ends of the outer tube and the actuatorrod. The ends of the tube and rod engage the slotted sleeve whenexpanding the slotted sleeve to an expanded position, which hooks intothe coiled structure for securing the actuator rod to the coiledstructure. The distal ends of the rod and the outer tube are beveled foreasing expansion of the slotted sleeve when the actuator rod iswithdrawn from the outer tube.

In still another aspect, the expandable means includes an expandablepliable material sleeve between the distal ends of the outer tube andthe actuator rod. The pliable material sleeve comprises, for example, apliable material such as synthetic rubber and the like, which expands ina radial direction when compressed between the distal ends of the outertube and the actuator rod to frictionally engage the coiled structureand secure the outer tube and actuator rod thereto. In anotherconfiguration, the pliable material sleeve has an outside dimensiongreater than the coiled structure passageway when the sleeve is in arelaxed position. The sleeve is stretched between the distal ends of theouter tube and actuator rod to reduce its outer diameter, which is theninsertable into the coiled structure passageway.

In yet another aspect, the expandable means of the lead removalapparatus includes projection means proximate a distal end of the outertube for hooking into the coiled structure. The control means furtherincludes a stylet for engaging and urging the projection means into thecoiled structure when positioned in the coiled structure passageway.

The lead removal apparatus may also be characterized as comprising tubemeans having a distal end for inserting into the passageway of thecoiled structure, expansion means positioned proximate a distal end ofthe tube means for hooking into the coiled structure of the pacemakerlead; and stylet means insertable into the tube means for engaging theexpansion means. As previously suggested, the tube means includes anouter tube having a passageway extending longitudinally therethrough.The stylet means includes a wire extending through the outer tubepassageway. And the expansion means includes a projection proximate thedistal end of the outer tube hooking into the coiled structure whenpositioned in the coiled structure and expanded outwardly from the outertube.

The lead removal apparatus may also be characterized as comprising anouter tube having a passageway extending longitudinally therethrough,which is sized for insertion into the passageway of the coiledstructure; an anchoring projection positioned proximal the distal end ofthe outer tube; and a stylet positioned through the outer tubepassageway and urging the anchoring projections between relaxed andhooked positions. In the hooked position, the anchoring projectionextends outwardly from the outer tube and when also positioned in thecoiled structure passageway hooks into the coiled structure. In therelaxed position, the anchoring projection is insertable into the coiledstructure passageway for positioning therein.

The foregoing problems are also solved and a technical advance isachieved with illustrative apparatus for removing an elongated structuresuch as a catheter or an electrical pacemaker lead implanted inbiological tissue such as a blood vessel or a heart cavity wall. Theillustrative apparatus includes a control unit having a longitudinalpassageway such as a flexible tube that is insertable in thelongitudinal passageway of the catheter or the wire coil of thepacemaker lead for controlling movement of the elongated structure.Positioned about the distal end of the control unit is an expandableunit that is operable to a position for securing the control unit to theelongated structure. The control unit passageway is used for operatingthe expandable unit.

In a first embodiment, the control unit is a flexible tube with one ormore side ports or apertures for passing a fluid therethrough foroperating the expandable unit. In this embodiment, the expandable unitis a balloon attached about the distal end of the tube with the sideports leading from the passageway for inflating or expanding the balloonto an expanded position for securing the control unit to the elongatedstructure.

In a second embodiment, the control unit again includes a flexible tube.The expandable unit includes a number of twisted radial projections eachhaving a free end that is formed from radial strips cut in the distalend of the tube. The strips are twisted at the free end and pushed intothe passageway of the tube. The apparatus further comprises an actuatorsuch as a rod that is inserted into the passageway of the tube to engageand expand the free end of the projections into the wire coil of thepacemaker lead, thereby securing the control tube to the wire coil.

In a third embodiment, a plurality of expandable strips arelongitudinally formed in the distal end of the control tube. Theactuating rod of the apparatus is inserted in the tube passageway andattached at the distal end of the tube. When the apparatus is insertedin the passageway of the elongated structure, the actuator rod is pulledin a direction out of the tube while operating the deformable stripsinto an expanded position engaging the wall of the structure passagewayfor securing the control tube to the elongated structure.

In a fourth embodiment, a number of barbs or a helical ridge is formedat the end of the control tube. The expandable distal end of the controltube is partially collapsed or formed such that the barbs or ridge whenexpanded by an actuator rod extend beyond the nominal diameter of thetube. The actuator rod is extended through the tube passageway to expandthe distal end of the tube and cause the barbs or ridge to engage thestructure and secure the control tube thereto.

In a fifth embodiment, the apparatus also includes a hollow control tubehaving a longitudinal passageway therein. An expandable slotted sleeveis positioned at the distal end of the control tube. An actuator rod isinserted through the slotted sleeve and control tube. The distal end ofthe rod is enlarged to engage and expand the slotted sleeve against thedistal end of the control tube. When inserted in the passageway of theelongated structure, the actuator rod is pulled in a direction out ofthe control tube passageway to force the enlarged distal end of the rodinto the passageway of the slotted sleeve and expand the slotted sleeveinto the wall of the elongated structure. As a result, the control tubeis secured to the elongated structure for controlling the movementthereof.

In sixth and seventh illustrative embodiments similar in function to thefifth embodiment, an expandable sleeve comprising a pliable material ispositioned between the distal ends of the control tube and actuatingrod. In the sixth embodiment, the pliable material sleeve is compressedbetween the distal ends of the control tube and actuator rod to expandand engage the passageway walls of the elongated structure. In theseventh embodiment, the pliable material sleeve is already in anexpanded position to engage the passageway walls of the elongatedstructure. To insert this expanded pliable material sleeve into thepassageway of the elongated structure, the actuator rod is pushed intothe passageway of the control tube to longitudinally stretch the pliablematerial sleeve. As a result, the outside diameter of the sleeve iscompressed to allow the apparatus to be inserted into the passageway ofthe elongated structure. When inserted, the actuator rod is releasedallowing the sleeve to radially expand and engage the wire coil orpassageway walls of the elongated structure.

The invention is further directed to removal apparatus having a guidethat is insertable into the passageway of the elongated structure forguiding the control unit in the passageway. In those instances where thepassageway of the elongated structure has become blocked or occluded,the apparatus advantageously includes this guide for breaking throughthe occlusion. Furthermore, various diameter guides are inserted intothe structure passageway for determining the minimum passageway diameterof the structure when the structure has in some way been deformed ordamaged. Illustratively, the guide includes a stylet wire that is firstinserted into the passageway of the elongated structure. When the styletguide has been inserted, the control tube is inserted over the proximalend of the stylet wire and inserted into the passageway of thestructure. In one embodiment, the expandable unit of the apparatusincludes a wire coil positioned around and attached at its distal end tothe control tube. When inserted, the control tube is rotated to expandthe wire coil and secure the control tube to the elongated structure.

In another embodiment, the expandable unit includes a balloon attachedabout the distal end of the control tube. The control tube includes asecond passageway that leads to the balloon for inflating the balloon tosecure the control tube to the passageway wall of the elongatedstructure.

The invention is also directed to a removal apparatus having a rotatableunit for securing the control unit to the elongated structure. In oneillustrative embodiment, the removal apparatus includes a control tubeinsertable into the passageway of the elongated structure forcontrolling the movement thereof. Positioned about the distal end of thecontrol tube is a rotatable unit such as a cylindrical rod that isrotatable to a position off-centered from the tube for securing thecontrol tube to the elongated structure. The apparatus also includes anactuator rod extending through the control tube and attachedoff-centered to the cylindrical rod for rotating the rod into theoff-centered position securing the control tube to the structure.

The invention is still further directed to removal apparatus having acontrol tube that is insertable into the passageway of the elongatedstructure and has an extended projection at the distal end thereof forsecuring the tube to the structure. Also included is a stylet that isinsertable into the passageway of the tube for operating the extendedprojection to a retracted position for insertion or removal of thecontrol tube from the passageway of the elongated structure.

The invention also includes apparatus for separating the elongatedstructure from tissue that is restricting the movement and,consequently, the removal of the elongated structure. In oneillustrative embodiment, the separating apparatus includes a tube havinga first passageway for receiving the elongated structure. Positionedabout the distal end of the tube is a balloon that is inflatable forseparating restricting tissue from a length of the elongated structure.A second passageway extending along the tube and to the balloon isincluded for inflating the balloon.

In another embodiment, the separating apparatus includes a first tubehaving a passageway for receiving the elongated structure and a distalend for separating the structure from the restricting tissue as theelongated structure is received into the passageway. Also included is asecond tube having a passageway for receiving the elongated structureand the first tube for separating the restricting tissue from either thefirst tube or the elongated structure. Advantageously, at least one ofthe two tubes comprises a polypropylene material, which is much lesssusceptible to kinking than teflon. In operation, two tubes arealternately moved along the elongated structure to provide tissueseparation. The second tube advantageously adding strength to theremoval apparatus for separating the restricting tissue. A controlmechanism having a passageway for passing the proximal end of theelongated structure therethrough is also attached to the proximal end ofthe first tube for controlling movement of the first tube in either arotational or longitudinal direction about the elongated structure. Tofacilitate visualization of the separating apparatus in biologicaltissue such as a blood vessel, at least one of the two tubes includes aradio-opaque material such as bismuth.

The invention also includes apparatus for separating the distal end ofan elongated structure such as a pacemaker lead from heart tissueaffixed thereto. In one illustrative embodiment, the separatingapparatus includes first and second concentric tubes each having apassageway for receiving the structure to the distal end thereof. Anelongated member such as stainless steel wire or suture material isextendable between the distal ends for cutting the distal end of thestructure from the tissue. When the tubes are positioned at the distalend of the coiled structure, the tubes are rotated in oppositedirections to wipe the wire or suture material across the distal ends ofthe tubes and structure, thereby cutting the distal end of the structurefrom the affixed tissue. At least one of the tubes also has a secondpassageway or channel for controlling the amount and the tension of theelongated means at the distal ends thereof.

In a second illustrative embodiment, the separating apparatus includes atube having a passageway for receiving the lead. The distal end of thetube is extendable to the distal end of the pacemaker lead. Included atthe distal end of the tube is a plurality of slots for receiving thetines of the pacemaker lead. When the tines have been positioned in oneor more of the slots, the tube is rotated for separating the tines anddistal end of the lead from the encapsulating tissue.

The invention is further directed to apparatus for expanding theproximal end of a severed coiled structure of a pacemaker lead.Advantageously, this expands the wire coil structure of a pacemaker leadto insert a sizing stylet or gauge to accurately determine the diameterof the wire coil of the pacemaker lead. When the connector end issevered from the proximal end of the pacemaker lead, the severingoperation deforms the wire coil and provides a false indication of thetrue diameter of the passageway extending to the distal end of the lead.The expanding apparatus includes a tapered rod having distal end with afirst diameter that is easily insertable into a passageway of the coiledstructure of the pacemaker lead. The rod has a tapered longitudinalportion extending from the distal end to a proximal end having a seconddiameter greater than the first diameter. The tapered portion engagesand expands the proximal end of the severed coiled structure wheninserted therein. The apparatus also includes a control mechanismattached to the rod for controlling movement of the rod in thepassageway of the coiled structure.

Lastly, the invention includes apparatus for removing an elongatedcoiled structure implanted in biological tissue such as the wire coil ofa pacemaker lead implanted in the heart through a blood vessel leadingthereto. The apparatus includes a stylet wire that is insertable into alongitudinal passageway of the coiled structure for controlling movementof the structure. A wire coil is attached at its distal end to thedistal end of the stylet wire and is expandable for securing the styletwire to the coiled structure. The proximal end of the wire coil isextended from the wire coil and stylet wire for engaging the coiledstructure and for controlling expansion of the wire coil.

In another illustrative embodiment of this removal apparatus, first andsecond coil means, such as a wire coil having respective first andsecond pluralities of turns, are positioned about the distal end of thestylet wire. The first coil means is attached about the distal end ofthe stylet wire and is radially expandable about the stylet wire forsecuring the stylet wire to the implanted lead when the stylet wire isinserted in the longitudinal passageway of the implanted lead. Thesecond coil means extends proximally from the first coil means andlaterally from the stylet wire for advantageously engaging the implantedlead and radially expanding the first coil means about the stylet wire.The second plurality of wire turns is formed to have a predeterminedlength and width for advantageously engaging the coil structure of theimplanted lead. Furthermore, the second plurality of wire turns andstylet wire cooperatively have a cross-sectional dimension approximatingthat of the implanted lead passageway. The first coil means alsoincludes a third plurality of closely-spaced wire turns that extendsdistally from the first plurality and that is positioned around andattached to the stylet wire. The second and third pluralities of wireturns cooperate to radially expand the first plurality of wire turns. Anenhancement to this illustrative embodiment includes a flat and atapered portion of the stylet wire that is positioned between the firstand third pluralities of wire turns for unremovably engaging the coiledstructure of the implanted lead. The width of this flat portionapproximates the width of the implanted lead passageway. The taperedportion extends proximally from the flat portion for advantageouslyexpanding the first plurality of wire turns within the passageway of theimplanted lead. The tapered portion more quickly expands the firstplurality of wire turns to engage the coiled structure of the implantedlead and secure it thereto without retraction of the stylet wire fromthe electrode of the implanted lead. In addition, the distal end of thestylet wire is tapered for easy insertion into the implanted leadpassageway.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 depicts a partial cross-sectional view of a heart having anelectrical pacemaker lead implanted therein;

FIG. 2 depicts a partial cross-sectional view of a prior art toolinserted in the passageway of a heart lead for removing the lead;

FIG. 3 illustrates sections of the apparatus of the present inventionfor separating a length of a heart lead restricted in a blood vessel andfor separating the tip of the heart lead from a heart cavity wall;

FIG. 4 illustrates the leading edge of the separator tube of theapparatus of FIG. 3 for separating the heart lead from a blood vessel aspartially shown in FIG. 1;

FIG. 5 depicts a lockable mechanism for grasping the proximal end of thepacemaker lead of FIG. 1;

FIG. 6 depicts an enlarged view of the lockable mechanism of FIG. 5along the lines 6--6;

FIG. 7 depicts another embodiment of the lead removal apparatus of thisinvention;

FIG. 8 depicts the lead removal apparatus of FIG. 7 with the styler wiresecured to the pacemaker lead;

FIG. 9 depicts a device for expanding the proximal end of the coiledstructure of FIG. 3;

FIGS. 10-21 depict alternative embodiments of the removal apparatus ofFIG. 3;

FIGS. 22 and 27 depict alternative embodiments of the apparatus forseparating encapsulating tissue from a pacemaker lead of FIG. 3;

FIG. 23 depicts an alternative embodiment of the apparatus for removingan elongated coiled structure implanted in biological tissue of FIG. 3;

FIGS. 24-26 depict illustrative apparatus for separating the distal endof an elongated structure from tissue affixed thereto;

FIG. 28 depicts an alternative embodiment of the apparatus for removingan elongated coiled structure implanted in biological tissue; and

FIGS. 29-31 depict an enhancement to the alternative embodiment of theapparatus for removing an elongated coiled structure implanted inbiological tissue of FIG. 28.

DETAILED DESCRIPTION

Depicted in FIG. 1 is a partial cross-sectional view of heart 215connected to a plurality of arteries and veins such as the rightsubclavian vein 216 through which an electrical heart pacemaker lead 204has been implanted. The lead passes internally through the rightsubclavian vein 216, the superior vena cava 208 and into the rightventricle 217 of the heart. The distal end of the lead includes anelectrode 220 for electrically stimulating the heart and is secured tothe apex of the right ventricle with a plurality of tines 207, which intime become securely attached to the ventricle wall by endothelialtissue forming around the heart lead tip. Some ventricles are relativelysmooth on the inside, but most have trabeculae amongst which the tinesare secured into position. External to the right subclavian vein, theproximal end 221 of the lead is grasped by a lockable mechanism 222,which will be described hereinafter.

Depicted in FIG. 2 is a partial cross-sectional view of a prior art tool100 for removing a heart lead 111 which has been secured to a heartcavity wall 113 via trabeculae and/or fibrotic tissue 104. The leadincludes an electrical coiled structure 101 and insulating material 102that is formed essentially into a tube for covering the outer surface ofthe coiled structure and for preventing fluids from entering the coiledstructure. At the distal end of the heart lead are tines 103, that areformed from the insulating material, for securing the heart lead tipincluding electrode 109 to the heart cavity wall. Tool 100 includes ahollow rigid tube 105 and beveled rod 106 for inserting in thelongitudinal passageway 110 of the heart lead coiled structure. In thepassageway of hollow tube 105 is an actuating wire 107 connected tobeveled rod 106. The trailing edge of the beveled rod and the leadingedge of the hollow tube are inclined at an angle for moving the beveledrod across the distal end of the hollow tube when the actuating wire ispulled. When moved, the beveled rod engages and deforms the heart leadcoiled structure as shown. The deformed coiled structure locks thehollow tube and beveled rod in place for limiting movement of the heartlead. However, once secured, beveled rod 106 may not be extracted frompassageway 110 of the coiled structure since the deformed coiledstructure prevents the beveled rod and actuating wire from traversingthe passageway. The prior art tool also includes a hollow dilator 108for sliding over the heart lead coil and separating the heart lead fromthe blood vessel. A hollow explanator 112 passes over the dilator and isrotated back and forth to explant the tip of the heart lead from thesecuring tissue and heart wall.

Depicted in FIG. 3 is a flexible stylet wire 200 of the present leadremoval apparatus invention that is insertable in the longitudinalpassageway 210 of a heart lead coiled structure 211 for controlling and,in particular, limiting the movement of heart lead 204 including coiledstructure 211. Heart lead 204 also includes insulating material 201,such as silicone or polyurethane, formed into a hollow tube thatsurrounds the coiled structure and prevents fluids from making contactwith the coiled structure. Attached to the distal end of the flexiblestylet wire is an expandable wire coil 205 consisting of approximately25 turns of wire with spacing between the turns. Five to seven wraps ofthe wire coil are attached to the distal end of the stylet wire using,for example, solder 206. The remaining wraps of the wire coil remainfree for engaging the coiled structure when the proximal end of thestylet wire is rotated in a direction to unwind and expand the turns ofthe wire coil and engage the coiled structure of the heart lead. A bead214 of high temperature silver solder is applied to the distal end ofthe stylet wire to prevent the distal end thereof from pulling throughthe wire coil during separation and removal of the heart lead.Positioned about the proximal end of the stylet wire is controlmechanism 202 for rotating the stylet wire in either a clockwise orcounterclockwise direction or for moving the wire in a longitudinaldirection into or out of the passageway. In this embodiment, controlmechanism 202 is a loop of wire formed from the stylet wire of which thephysician may grasp or insert his finger. The loop may also be fashionedfor attachment to another control mechanism for moving the stylet wire.Other control mechanisms such as a slidable chuck may be positioned atthe proximal end of the stylet wire to facilitate movement of the styletwire. The formed loop 202 is covered with teflon tubing 203 or othersuitable material for facilitating the easy movement of the stylet wire.The looped end is also compressible for inserting through a separatortube 212.

The choice of the stylet wire and wire coil varies with the internaldiameter of the coiled structure which varies from 0.016" to about0.028" for most heart leads. The diameter of the stylet wire would thenrange from 0.009" to 0.015", with the coil wire ranging in diameter from0.003" to 0.006". The use of stainless steel wire is preferable. Thestylet wire should be hardened wire, but ductable wire may be used forthe coil wire.

Before the stylet wire is inserted into passageway 210 of the lead, theinside diameter of the coiled structure and the outside diameter of theinsulating material are determined. First, lockable mechanism 222 isfirst applied to the proximal end 221 of the lead between opposingsemicircular jaws 223 and 224. The details of mechanism 222 are depictedin FIGS. 5 and 6. Semicylindrical pliable material 225 and 226, such aslatex, are affixed with medical grade adhesive to the opposing faces ofthe jaws. Semicylindrical pliable material 225 includes semicylindricalchannels 227 and 229 having different radii, and pliable material 226includes semicylindrical channels 228 and 230 with radii correspondingto channels 227 and 229, respectively. When jaws 223 and 224 are in aclosed position, the opposing surfaces 231 and 232 of respective pliablematerial 225 and 226 are in contact with opposing channels 227 and 228forming one hollow cylindrical passageway with a first diameter andopposing channels 229 and 230 forming a second hollow cylindricalpassageway with a second larger diameter. The two different sizediameter passageways in the pliable material accommodate a number ofdifferent size diameter pacemaker leads and are designed to grasp andapply pressure to insulating material 201 in a uniform manner.

When proximal end 221 of lead 204 is inserted and grasped in the hollowpassageway formed by channels 229 and 230, insulating material 201 iscompressed onto coiled structure 211, thus limiting the movement of thestructure within the insulating material. When the physician cuts thelead for access to the passageway of the lead, the compressed insulatingmaterial prevents the coiled structure from retracting into thepassageway of the lead.

Pivotly interconnected elongated members 233 and 234 are connected torespective opposing jaws 223 and 224 to operate the jaws between openand closed positions. The proximal ends 235 and 236 of the members arecurved as shown in FIG. 5 to oppose each other and have a respectiveplurality of teeth 237 and 238 that interlock to form a lockingmechanism. The locking mechanism is actuated by squeezing the proximalends of the members and opposingly positioning the teeth thereon. Whenso positioned, the teeth of mechanism 222 interlock and maintainopposing jaws 223 and 224 in a closed position.

After the lockable mechanism is applied to the proximal end of thepacemaker lead, a pair of well-known wire cutters or snips sever theelectrical connector (not shown) from the proximal end 222 of pacemakerlead 204. As a result of such severance, coiled structure 211 of thepacemaker lead is commonly deformed, thereby presenting a falseindication of the actual diameter of longitudinal passageway 210. As aconsequence, the physician inserts expansion device 901 into theproximal end of hollow passageway 210 to expand coiled structure 211.

Depicted in FIG. 9 is expansion device 901 for expanding the deformedproximal end of coiled structure 211. The expansion device includes atapered rod 902 having a distal end 903 with a diameter that is easilyinsertable into the passageway of the deformed coiled structure. Taperedrod 902 includes a tapered longitudinal portion 904 that graduallyincreases in diameter to proximal end 905 that has a diametersignificantly greater than the diameter of the distal end. Controlhandle 906 is connected to the proximal end of the tapered rod. Thephysician grasps the control handle to insert the tapered rod into thelongitudinal passageway and to expand the deformed proximal end of thecoiled structure.

With lockable mechanism 222 in a closed position and the proximal end ofthe coiled structure expanded, the physician selects a wire guide 239,as shown in FIG. 3, having a diameter less the diameter of the leadpassageway. The physician determines the passageway by inserting thewire guide therein and sensing for any blockages. The guide includes acontrol mechanism such as a knurled cylindrical chuck 240 positionableabout the proximal end thereof. The physician grasps the knob to extendthe guide into the lead passageway and to rotate the guide back andforth to clear or break through any blockages caused by tissue oroccluding material. The guide is also used to determine or size theinside diameter of a second coiled structure that may be coaxiallypositioned inside coiled structure 211. When utilized as a controlmechanism for stylet wire 200, the chuck may also include appendages 260for rotating and counting the number of times the stylet wire isrotated. Having determined the lead passageway with the wire guide,several other guides similar to guide 239 are individually inserted inthe passageway to determine the actual inside diameter at the proximalend. Guide 239 is also utilized to determine if coiled structure 211 hasbeen deformed or damaged and to determine the smallest diameter of thecoiled structure and passageway.

As shown in FIG. 3, stylet wire 200 is inserted into longitudinalpassageway 210 of coiled structure 211. The diameter of the coil wireand stylet wire have been selected to form a combined overall diameterwhich approximates the diameter of the longitudinal passageway of theheart lead coiled structure within a predetermined tolerance such as oneor two thousandths of an inch. Stylet wire 200 is then fed through theentire length of the passageway to the distal end of the coiledstructure which is secured to the wall of heart cavity tissue 213 viatines 207. When fully inserted into the heart lead, the distal ends ofthe stylet wire and coiled structure should be in close proximity. It isnot necessary, but probably more advantageous, that the stylet wire beattached to the distal end of the heart lead. For separating the heartlead from adjacent tissue, the stylet wire may be secured anywhere alongthe passageway of the coiled structure past the restricting tissue. Tosecure the stylet wire to coiled structure 211, looped end 202 of thestylet wire is operated in a circular direction to unwind and expandwire coil 205. As a result, the turns of the wire coil and coiledstructure engage and intermesh, thereby firmly securing the stylet wireto the heart lead. This prevents any extension or stretching of theheart lead and also controls and limits the movement of the lead whenseparator tube 212 is moved along the length of coiled structure 211 andinsulating material 201 of the heart lead.

Depicted in FIG. 23 is illustrative removal apparatus 2301, which is analternative embodiment of stylet wire 200. Removal apparatus 2301 isinsertable into the longitudinal passageway of an elongated structuresuch as a pacemaker lead. The removal apparatus includes a stylet wire2302 with a conically-shaped silver solder tip 2303 that is positionedat the distal end thereof. Closely wrapped wire coil 2304, similar towire coil 205, is attached at the distal end of the stylet wire usingsilver solder 2305 as previously described. The proximal end of the wirecoil is pulled to unwrap several turns of wire coil 2304. A pigtail 2306is formed from the proximal end of the wire coil to extend in a radialdirection from the wire coil and stylet wire. Pigtail 2306 catches on orengages the coiled structure of the pacemaker lead to engage wire coil2304 with the coiled structure of the pacemaker lead. In addition, thewire coil may be rotated in the opposite direction to release the styletwire from the coiled structure if desired.

Depicted in FIG. 28 is illustrative removal apparatus 2801, which is analternative embodiment of stylet wire 200. Removal apparatus 2801 isinsertable into the longitudinal passageway of an elongated structuresuch as a pacemaker lead. The removal apparatus includes stylet wire2802 comprising commercially available stainless steel wireapproximately 0.021" in diameter and 61 cm in length. Stylet wire 2801has distal end 2803 which is tapered into a conical shape for anapproximate length of 4 cm for easy insertion into the pacemaker leadpassageway. Tapered distal end 2803 is shaped using any of a number ofwell-known techniques such as sanding, grinding, buffing, or acombination thereof. The removal apparatus also includes wire coil 2804comprising commercially available Tophel wire approximately 0.0045" indiameter. Wire coil 2804 is positioned around and about stylet wire 2802and comprises central plurality of wire turns 2805. Central plurality2805 extends longitudinally from approximately 20 cm and comprises wireturns with a spacing of approximately 0.035" therebetween. Wire coil2804 further comprises a proximal plurality of wire turns 2806, whichextends proximally from the central plurality and laterally from thestylet wire, and a distal plurality of wire turns 2807, which extendsdistally from the central plurality. Proximal plurality of wire turns2806 has a nominal outside diameter of 0.010" and a maximum diameterwidth of 0.012". The proximal plurality is formed from turns having an0.010" inside diameter that are stretched to an outside diameter ofapproximately 0.010", thus increasing the spacing between each turn. Thelength of the proximal plurality is trimmed to a length of approximately12 mm. When inserted in the lead passageway, the stylet wire andproximal plurality in combination have a cross-sectional dimension thatapproximates that of the passageway for engaging the coiled structure ofthe lead and radially expanding the central plurality of wire turns. Thedistal plurality comprises approximately five turns with minimal spacingtherebetween, much less than that of central plurality 2805. The distalplurality of wire turns is wrapped about the distal end of the styletwire next to silver solder bead 2808 and attached thereto withtin-silver solder 2809. The silver solder bead and distal plurality ofwire turns are tapered into a conical shape having a maximum outsidediameter of, for example, 0.030" for easy insertion in the passageway ofthe lead.

When apparatus 2801 is positioned in the passageway of an implantedpacemaker lead, in particular a lead having a 0.030" diameterpassageway, the proximal plurality of wire turns creates an interferencefit in the passageway. During insertion to distal end of the pacemakerlead, the apparatus is alternately pushed distally and pulled proximallya short distance for maintaining the interference fit effected by theengagement of the proximal plurality with the coiled structure of thepacemaker lead. When the distal end of the stylet is positioned in thepassageway of the distal end of the pacemaker lead, stylet wire 2801 isrotated in a counter-clockwise direction for unwrapping several turns ofcentral plurality 2805. The unwrapped turns of the central pluralityfurther engage and secure the wire coil of the apparatus with the coiledstructure of the pacemaker lead.

Depicted in FIGS. 29 and 30 is illustrative removal apparatus 2901,which represents an enhancement to apparatus 2801 of FIG. 28. Removalapparatus 2901 includes stylet wire 2902 of commercially available0.021" diameter stainless steel wire having tapered portion 2903, flatportion 2904, and distal end 2905. Removal apparatus 2901 furtherincludes wire coil 2906 having a central plurality of wire turns 2907, adistal plurality of wire turns 2908, and a proximal plurality of wireturns 2910. Wire coil 2906 also includes a somewhat straight portion2909 extending longitudinally between the central and distalpluralities. Distal plurality 2908 is closely spaced, much less than thecentral plurality, and fixedly attached with tin-silver solder 2911about the distal end of the stylet wire next to silver solder bead 2912.As shown in the top view of FIG. 30, tapered portion 2903 and flatportion 2904 of the stylet wire is positioned between the distal andcentral pluralities of wire turns and has a maximum width of 0.030" thatapproximates the width of the passageway of the implanted lead. Straightportion 2909 of the wire coil extends longitudinally from the centralplurality along stylet wire 2902 where the diameter of the stylet wireis uniform. Straight portion 2909 further extends longitudinally alongtapered portion 2903, which has a 30 degree tapered edge, and flatportion 2904, which has an edge parallel the stylet wire. Taperedportion 2903 and flat portion 2904 are each approximately 0.15" long.

As depicted in FIG. 31, removal apparatus 2901 is positioned inpassageway 3001 and secured to coiled structure 3002 of implantedpacemaker lead 3003. Stylet wire 2902 has been rotated in acounter-clockwise direction to wrap straight coil portion 2909 aroundtapered stylet portion 2903. The wrapped straight coil portion engagesthe coiled structure of the lead and secures the stylet wire to theimplanted lead. As the straight coil portion is wrapped around thetapered stylet portion, turns of the central plurality move distally toexpand and engage the tapered stylet portion and the coiled structure ofthe implanted lead.

Depicted in FIGS. 10-21 are alternative embodiments of illustrativeapparatus for removing the elongated structure implanted in biologicaltissue. All of these alternative embodiments are for controlling themovement of an elongated structure. The removal apparatus in each ofthese alternative embodiments includes a control unit that is insertableinto the longitudinal passageway of the elongated structure, such as apacemaker lead, and securable to the structure for controlling themovement thereof. The apparatus also includes an expandable unitpositioned about the distal end of the control unit and operable to anexpanded position for securing the control unit to the elongatedstructure. However, the control unit in each of these alternativeembodiments commonly, but not in all cases, includes a longitudinalpassageway for operating the expandable unit to the expanded positionfor securing the control unit to the elongated structure.

Depicted in FIG. 10 is a first alternative embodiment of illustrativeremoval apparatus 1001 for removing implanted pacemaker lead 204. Thecontrol unit of this removal apparatus includes a flexible tube 1002having a passageway 1003 formed longitudinally therein. Expandableballoon 1004 is positioned and attached about the distal end of thecontrol tube. The distal end of the control tube is also recessed toattach to the balloon in a well-known manner at the ends of radialrecess 1005. The recess also provides a volume in which the collapsedballoon is stored. The recess also includes one or more side ports 1006leading from passageway 1003 to the balloon. A source of fluid such ascompressed air or liquid is passed through the passageway and into theballoon to inflate the balloon to an expanded position as indicated byexpanded balloon 1007 positioned at the distal end of the lead.

Depicted in FIG. 11 is a second alternative embodiment of illustrativeremoval apparatus 1100. In this second alternative embodiment, thecontrol unit also includes a control tube 1101 for insertion intopassageway 210 of coiled structure 211. The expandable unit comprises aplurality of radial projections 1102 and 1103 that have a free end andare radially formed in the distal end of the control tube. The free endof the radial projection is twisted and bent in an inward direction intopassageway 1104 of the control tube. As formed, these projections allowa control tube to be easily inserted into passageway 210 of the coiledstructure. When control tube 1101 is positioned at the distal end of thecoiled structure, actuator rod 1105 is inserted in passageway 1104 ofthe control tube. When inserted, the actuator rod engages the radialprojections and forces them into an expanded position extending radiallyfrom the surface of the control tube into the coiled structure of thepacemaker lead. When in the expanded position, these radial projectionssecure the control tube to the coiled structure, thereby controllingmovement of the coiled structure during removal from the tissue.

Depicted in FIG. 12 is a third alternative embodiment of illustrativeremoval apparatus 1201 utilizing an actuator rod 1202. The removalapparatus includes a control tube 1203 that is extendable into thelongitudinal passageway of a pacemaker lead. The expandable unit of theapparatus comprises a plurality of longitudinal strips 1204 formed atthe distal end of the control tube. Actuator rod 1202 is inserted in thepassageway of the control tube and attached to the distal end 1205thereof. When the control tube is inserted in the longitudinalpassageway of the pacemaker lead, the actuator rod 1202 is pulled in alongitudinal direction out of passageway 1206 of the control tube asshown by arrow 1207. Typically, the physician will maintain the relativeposition of the proximal end of control tube 1203 while the actuator rodis pulled in the outward direction. As a result, distal end 1205 isforced toward the proximal end of the control tube, as shown by arrow1208, thereby deforming longitudinal strips 1204 in an outward directionas indicated by arrows 1209. The expanding strips engage the coiledstructure and secure the control tube to the coiled structure of thepacemaker lead.

Depicted in FIG. 13 is a fourth embodiment of illustrative removalapparatus 1301 inserted in the longitudinal passageway 210 of coiledstructure 211. Removal apparatus 1301 includes a control tube 1302having a distal end with a spiral or helical ridge 1303 formed therein.Alternatively, a number of barbs are formed in the contoured distal endof control tube 1302. The distal end includes a plurality of slits 1307or an opening thereat for expanding the ridge or barbs into the coiledstructure. Actuator rod 1304 is inserted into passageway 1305 to engagethe distal end. When engaged, actuator rod expands the ridge or barbs ina radial direction, as shown by arrows 1308, to engage the coiledstructure of the pacemaker lead. As a result, the expanded ridge orbarbs secure the control tube to the coiled structure for controllingthe movement thereof.

Depicted in FIG. 14 is a fifth embodiment of illustrative removalapparatus 1401 inserted in longitudinal passageway 210 of coiledstructure 211. The removal apparatus includes control tube 1402 andactuator rod 1403 extending through hollow passageway 1404 of thecontrol tube. The apparatus also includes a diagonally-slotted sleeve1405 that is positioned between the distal ends of the control tube andactuator rod. The actuator rod also extends through hollow passageway1406 of the sleeve. Attached to the distal end of the actuator rod isbeveled tip 1407 having an outside diameter approximating the diameterof the control tube and the nominal diameter of the slotted sleeve.Similarly, the distal end of the control tube is beveled to engage andexpand the slotted sleeve. To expand the slotted sleeve, the actuatorrod is pulled, as indicated by arrow 1408, to engage the sleeve againstthe beveled edges of the control tube and the rod. As a result, thesleeve is expanded to a position for engaging coiled structure 211 andsecuring the control tube thereto. The slotted sleeve expands in aradial direction as indicated by arrows 1409.

Sixth and seventh alternative embodiments of illustrative removalapparatus 1501 and 1601 are depicted in FIGS. 15 and 16, respectively.In FIG. 15, removal apparatus 1501 includes a control tube 1502 and anactuator rod 1503 extending through longitudinal passageway 1504 of thecontrol tube. The distal end of the actuator rod includes enlarged tip1505 having a diameter approximating the diameter of the control tube.The device also includes expandable sleeve 1506 comprising a pliablematerial such as synthetic rubber and the like which expands in a radialdirection when compressed between the distal end of the control tube andthe enlarged tip of the actuator rod. In the relaxed state, the outsidediameter of the pliable material approximates that of the control tubeand enlarged tip of the actuator rod for insertion into longitudinalpassageway 210 of the coiled structure. When inserted into passageway210, the enlarged tip and distal end of the control tube compress andradially expand the pliable material in an outward direction toward thecoiled structure as indicated by arrows 1507. The actuator rod is pulledthrough the passageway of the control tube as indicated by arrow 1508.As a result, pliable material 1506 is longitudinally compressed as shownby arrows 1509 and 1510. However, pliable material 1506 also expands ina radial direction and engages the coiled structure, thereby securingthe control tube thereto.

Similarly, illustrative removal apparatus 1601 depicted in FIG. 16includes control tube 1602 having longitudinal passageway 1610, actuatorrod 1603 having an enlarged distal tip 1604, and pliable material 1605attached to the distal end of control tube 1602 and enlarged actuatorrod tip 1604. However, unlike pliable material 1506, pliable material1605 in a relaxed condition has an outside diameter greater than thediameter of longitudinal passageway 210. Therefore, to insert theremoval apparatus in the passageway, actuator rod is forced intopassageway 1610 as indicated by arrow 1606, thereby stretching pliablematerial 1605 as indicated by arrows 1607 and 1608. As a result, theoutside diameter of the pliable material decreases as indicated byarrows 1609 for insertion into the passageway of the elongatedstructure. When inserted, the actuator rod is released, and the pliablematerial attempts to return to its relaxed state. As a result, thepliable material engages the coiled structure and secures the device tothe pacemaker lead.

Depicted in FIGS. 17 and 18 are alternative embodiments of illustrativeremoval devices 1701 and 1801 that include a wire guide for insertinginto the longitudinal passageway of the elongated structure. In FIG. 17,removal apparatus 1701 includes wire guide 1702 that is inserted intopassageway 210 of coiled structure 211 to clear any blockage formedtherein and establish a guide for control tube 1703. When the guide wireis fully inserted, the control tube is inserted over the guide wire andthen into passageway 210 of the structure. The control tube also has alongitudinal passageway 1706 for receiving the wire guide therein. Alsoincluded is wire coil 1704 that is positioned and attached at the distalends thereof using, for example, silver solder 1705. As previouslydescribed with respect to stylet wire 200, control tube 1703 is rotatedin a direction opposite that of coiled structure 211 for engaging andexpanding wire coil 1704, thereby securing the control tube to thecoiled structure.

As depicted in FIG. 18, removal apparatus 1801 includes wire guide 1802that is inserted into the passageway of the elongated structure. Controltube 1803 includes two longitudinal passageways 1804 and 1805.Passageway 1804 receives the wire guide as the control tube is insertedinto the passageway of the elongated structure. Positioned at the distalend of the control tube is inflatable balloon 806 with passageway 1805leading thereto through sideport or aperture 1807. To secure the controltube to the elongated structure, a fluid is passed through passageway1805 to inflate the balloon to an expanded position.

Several other alternative embodiments of illustrative removal apparatusare depicted in FIGS. 19-21. Depicted in FIG. 19 is removal apparatus1901 that includes control tube 1902 and cylinder 1903. The tubeincludes longitudinal passageway 1904. Cylinder 1903 is positioned aboutthe distal end of the control tube and rotated to a position off-centerof the tube for securing the control tube to the elongated structure.The removal apparatus includes an actuator rod 1904 extending throughthe control tube and attached to the rotatable cylinder. The rod rotatesthe cylinder to an off-centered position for securing the control tubeto the elongated structure such as the coiled structure of a pacemakerlead. Actuator rod 1904 extends between the rotatable cylinder andcontrol mechanism 1905 that is positioned at the proximal end of thecontrol tube. Control mechanism 1905 is rotatable between two positionsfor rotating the actuator rod and the cylinder between expanded andretracted positions. The actuator rod is attached to the cylinder at anoff-centered position to permit rotation of the cylinder and engagementof the elongated structure. Plug 1907 is inserted at the distal end ofthe tube to maintain the off-centered position of the rod in thepassageway.

Depicted in FIG. 20 is illustrative removal apparatus 2001 including acontrol tube 2002 that has a longitudinal projection 2003 extending atthe distal end thereof for securing the control tube to the coiledstructure of a pacemaker lead. This arrangement is sometimes referred toas a flea-clip arrangement. Depicted in FIG. 21 is a sectioned view,taken along the lines 21--21 in FIG. 20, of the apparatus in passageway210 of coiled structure 211. As shown, a stylet wire or rod 2004 isinserted into passageway 2005 of control tube 2002 to engage and retractthe extended projections into the wall of the control tube. When theapparatus is inserted to the distal end of the coiled structure, thestylet wire or rod is removed from the passageway of the control tube.As a result, the spring-like projections extend into the coiledstructure of the lead, thereby securing the control tube to the coiledstructure for controlling the movement thereof. To remove the controltube, the rod is inserted into the control tube passageway as shown byarrow 2101 to again engage the projections. When the rod engages theprojections extending into the passageway, the inward extendingprojections move into the wall in a direction as shown by arrows 2103,whereas the outward extending projections move into the wall in adirection as shown by arrows 2102.

The reader's attention is again referred to the preferred embodimentdepicted in FIG. 3. After the stylet wire is secured to the lead andprior to inserting separator tube 212 over the stylet wire and lead, atie 241 of, for example, nylon cord or suture material is wrapped aroundproximal end 221 of the lead to secure insulating material 201 to coiledstructure 211. The tie controls or limits the movement of the coiledstructure within the insulating material. With the insulating materialsecured to the coiled structure at the proximal end, removal force isapplied not only to the coiled structure, but also to the insulatingmaterial of the lead as well. This maintains the integrity of the heartlead during subsequent tissue separation from the insulating material.In those instances where the stylet wire has not been fully inserted tothe distal end of the lead, the tie also prevents the coiled structurefrom unravelling, breaking or separating from electrode 220 or the restof the lead.

As previously suggested, the looped proximal end of the stylet wire canbe compressed to permit separator tube 212 to be inserted thereover andover the insulating material of the heart lead. Separator tube 212comprises a semi-rigid material, such as teflon, for sliding easilythrough the blood vessel and over the insulating material of the heartlead. In order to place the separator tube over the stylet, the styletshould extend at least 12 inches beyond the person's body so that thelooped end can be grasped to apply tension to the stylet. With theteflon separator tube 10 to 12 inches long, the stylet is typicallythree feet long.

Depicted in FIG. 4 is fibrotic tissue 209 encapsulating heart lead 204in blood vessel 216. When this occurs in small diameter veins whereblood flow has been restricted or prevented, separation and removal ofthe lead from the tissue is difficult and often causes severe damage ordestruction to the vein. Without tension on stylet wire 200, separationis usually not possible in these situations.

As shown, the distal end of the teflon separator tube 212 is beveled andincludes a cutting edge or edge having a number of teeth for separatingheart lead insulating material 201 from encapsulating fibrotic tissue209. As depicted in FIG. 7, hollow separator tube 212 has a metalbeveled tip 242 attached to the distal end thereof with, for example, amedical grade adhesive. The metal tip provides a more durable edge forseparating or cutting encapsulating fibrotic tissue from the lead.

Returning the reader's attention again to FIG. 3, separator tube 212 ismoved and rotated along the outer surface of insulating material 201 ofthe heart lead to separate the lead from the blood vessel wall. Afterthe separator tube has been moved along the entire length of the heartlead, it will abut next to the heart cavity wall as shown by phantomlines 219. The distal end of the heart lead is typically secured to theheart cavity wall by trabeculae or fibrotic tissue 218 that hasencapsulated tines 207 positioned at the distal end of the lead. Theseparator tube 212 is positioned next to the heart cavity wall or pushedslightly while the stylet wire is tensioned in the opposite direction.The separator tube is then rotated back and forth to dislodge andseparate tines 207 and the distal end of the heart lead from fibrotictissue 218 and heart cavity wall 213. As a result, the heart lead hasnow been completely separated from the blood vessel and the heart cavitywall for subsequent removal. The separator tube, the stylet wire, andthe heart lead are then removed from the heart cavity and surroundingblood vessel.

However, should the removal of the heart lead be prevented for whateverreason, the stylet wire is rotated in a clockwise direction to unsecurethe stylet and wire coil from the heart lead coiled structure. The timefor this operation is lessened by attaching a rotating mechanism such asan electrical screwdriver to the proximal end of the stylet wire.

Depicted in FIG. 27 is an alternative embodiment of illustrativeseparator apparatus 2700. This separator apparatus includes a set ofseparator and dilator tubes 2701 and 2702 for insertion over pacemakerlead 204. Similar to separator tube 212, separator tube 2701 has ahollow passageway therein for receiving the pacemaker lead. Theseparator tube is advanced along the lead to engage and separateencapsulating tissue from the lead. Dilator tube 2702 similarly has ahollow passageway therein for receiving separator tube 2701 and thepacemaker lead therein. A preferred material for separator and dilatortubes 2701 and 2702 is polypropylene which is more kink-resistant thanteflon. A polypropylene tube fits easily into the blood vessel forextension to the distal end of the pacemaker lead. Furthermore, theinclusion of approximately 25% of bismuth provides radio-opacity forviewing with, for example, a fluoroscope during insertion of theseparator tube. When the dilator tube is inserted over the separatortube and lead, a control mechanism 2703 having a hollow passagewaytherein is inserted over the lead and connected to the proximal end ofseparator tube 2101. Control mechanism is well-known as a pinvise and isused for controlling the movement of the separator tube in both alongitudinal and rotational direction. The dilator tube and separatortube are alternatively moved along the lead to first separate the tissuefrom the lead and further dilate the tissue with the dilator tube. Thecontrol mechanism 2103 provides added strength and control during themovement of the separator tube. Dilator tube 2102 not only providesextra dilation of the tissue but also provides additional strength tothe entire structure for separating tissue from the pacemaker lead.

Depicted in FIG. 22 is another alternative embodiment of illustrativeseparator apparatus 2201 for separating encapsulating tissue 2205 frompacemaker lead 204. The separator apparatus 2201 includes a tube 2202having a longitudinal passageway 2203 therein for receiving and passingover the pacemaker lead including outer insulating material 201. Distalend 2204 of the tube is beveled to provide a wedge for separatingencapsulating tissue 2205 from the pacemaker lead. Also positioned andattached in a well-known manner about the distal end of the separatortube is balloon 2206. The tube also includes a plurality of hollowpassageways 2207 for supplying a compressed gas or fluid for inflatingthe balloon. Separator apparatus is inserted over the insulatingmaterial sheath of the pacemaker lead to engage encapsulating tissue2205. The beveled distal end provides a wedge for causing an initialseparation of the tissue from the lead. Upon initial contact andseparation, the balloon is inflated to provide further dilation andseparation of the encapsulating tissue from the pacemaker lead. Theballoon is then deflated to permit the beveled distal end to be furthermoved along the pacemaker lead and engage additional encapsulatingtissue. This process is continued until all of the encapsulating tissueis separated from the pacemaker lead.

Depicted in FIGS. 24 and 25 is separator apparatus 2401 for separatingthe distal end of an elongated structure such as electrode tip 220 ofpacemaker lead 204 from tissue 218 affixed thereto. This apparatus isparticularly advantageous in those instances where the electrode of thepacemaker lead is porous allowing fibrotic tissue to grow therein andsecure the electrode tip thereto. Separator apparatus includes a firsttube 2402 having a hollow passageway 2403 for receiving pacemaker lead204 and extending to the distal end thereof. Attached to the distal endof the first tube 2402 is an elongated member such as stainless steelwire 2404. The first tube wall also has a hollow channel or passageway2408 extending longitudinally therethrough for passing the wire theentire length of the tube. Alternatively, the stainless steel wire canbe affixed to the distal end using any suitable well-known fasteningmeans. A second tube 2405 also has a longitudinal passageway 2406 forreceiving the first tube. In addition, the second tube similarlyincludes a hollow channel or passageway 2407 for extending stainlesssteel wire 2404 through the entire length of the tube and beyond theproximal end thereof. This permits the loose end of the wire to becontrolled by the clinician to remove the distal end of the pacemakerlead from the encapsulating or affixed tissue. As shown in FIG. 25, thefirst tube is extended to the distal end of the pacemaker lead andplaced next to electrode 220. The second tube with the stainless steelwire is then also positioned next to the distal end of the pacemakerlead next to the electrode. The clinician puts tension on the stainlesssteel cutting wire and then rotates the second tube relative to thefirst causing the stainless steel wire to wipe across the face of theelectrode as shown. Rotation of the two tubes are shown by arrows 2501and 2502. This wiping motion across the pacemaker electrode literallycuts the electrode tip free from the encapsulating or affixed tissue218. Instead of stainless steel wire, suture material is also used toperform the cutting action.

Depicted in FIG. 26 is a second alternative embodiment of illustrativeseparator apparatus 2601 for separating the distal end of a pacemakerlead having a plurality of tines such as tines 207 of pacemaker lead 204encapsulated in fibrotic heart tissue 218. Apparatus 2601 includes tube2602 having a longitudinal passageway 2605 for receiving pacemaker lead204. The tube is inserted over the lead and extended to the distal endthereof. The tube includes a plurality of slots 2603 formed at thedistal end for receiving pacemaker lead tines 207. When the tines arereceived in the slots, tube 2602 is rotated back and forth in a circularmotion for dislodging and separating the tines from the encapsulatingtissue 218 extending from heart wall tissue 213.

Depicted in FIG. 7 is another illustrative embodiment of the leadremoval apparatus of this invention. In this embodiment, pacemaker lead243 is similar to the lead shown in FIG. 3; however, the distal end ofthe lead is of a different configuration. In particular, electrode 244has two cavities therein. One cavity is for receiving the coiledstructure 245 of the lead. The second cavity is for receiving andsecuring anchoring coil 246 secured in the cavity with insulatingmaterial 247 in a well-known manner. The distal end of anchoring coil246 is cut to form a beveled or sharpened edge for turning orcorkscrewing the coil into heart cavity wall 213. Anchoring coil 246, asa result, securely attaches electrode 244 to the heart tissue toestablish good electrical contact for stimulating the heart tissue withelectrical pacing pulses from the pacemaker. Insulating material 248surrounds coiled structure 245 and partially surrounds electrode 244.Since anchoring coil 246 is utilized in this configuration, theinsulating material is molded over the coiled structure and electrodewithout forming tines for the endothelial tissue to form therearound.

Stylet wire 249 of this lead removal apparatus and lock wire 250attached to the distal end thereof have a combined diameter much lessthan the inside diameter of coil structure 245 of the lead. This isparticularly advantageous for those situations when the coiled structureof the lead has been deformed, unraveled, or in some way damaged. Inthis embodiment, lock wire 250 has a plurality of turns 251 wrappedaround the distal end of the stylet wire. Turns 251 of the lock wire atthe distal end of the stylet wire are closely wrapped and attached tothe distal end of the stylet wire using, for example, a silver solder.Turns 252 of the lock wire are more loosely wrapped and areapproximately 75 in number. The unwrapped proximal end 253 of the lockwire extends beyond the passageway of the lead and is secured andpositioned by, for example, the physician's hand 258 when the styletwire is rotated to expand lock wire turns 252 and engage the turns ofcoiled structure 245.

Control mechanism 254 such as a loop of malleable wire is wrapped aroundand secured to the proximal end of the stylet wire using, for example,silver solder 257. Slidable chuck 240 is also suitable for use as thecontrol mechanism for stylet wire 249. A teflon coating 255 surroundsthe interconnection to prevent possible injury to the physician orpatient. Control loop 254 is provided for the physician to move thestylet wire in and out of the passageway of the lead as well as rotatethe stylet wire to engage the coiled structure of the lead. When thestylet wire is secured to the pacemaker lead, loop 254 is used toextract stylet wire and pacemaker lead from the patient.

To unravel the turns of the lock wire, a tool such as an electricalscrewdriver is attached to the control mechanism loop to rotate thestylet wire and expand the turns of the lock wire. While the stylet wireis being rotated, the physician secures the position of the proximal end253 of the lock wire to permit lock wire turns 252 to tangle and form abundle 259 that engages the coiled structure as depicted in FIG. 8. Thestylet may have to rotate 50 to 100 turns to form bundle 259 and engagecoiled structure 245.

After the lock wire has secured the stylet wire to the pacemaker lead,the physician grasps control loop 254 and continues to rotate the styletwire and pacemaker lead to dislodge anchoring coil 246 from the hearttissue. Should the blood vessels encapsulate the pacemaker lead,separator tube 212 is inserted over the stylet wire and pacemaker leadas previously described to separate the lead from the encapsulatingblood vessel tissue. The separator tube may also be extended to thedistal end of the pacemaker lead to turn and dislodge the distal end ofthe pacemaker lead from the heart tissue.

Of course, it will be understood that the aforementioned lead removalapparatus and method is merely illustrative of the application of theprinciples of this invention and that numerous other arrangements may bedevised by those skilled in the art without departing from the spiritand scope of the invention. In particular, a number of other controlmechanisms may be attached to the proximal end of the stylet wire foroperating the stylet wire in either a clockwise or counterclockwisedirection as well as moving the wire longitudinally. Furthermore, thisapparatus may be utilized for removing electrical leads from body ductsand passages as well as body tissue that has encapsulated the lead andrestricted its movement.

What is claimed is:
 1. Lead removal apparatus for removing an implanted,cardiac lead including a coiled structure having a passageway extendinglongitudinally therein, comprising:a tube; control means for moving saidcoiled structure when secured to said coiled structure, said controlmeans slidably arranged in said tube, said control means having a distalend that is configured for insertion into said passageway of said coiledstructure; and expandable means other than and separate from said tubepositioned proximate said distal end of said control means and having anexpanded position in said passageway of said coiled structure forsecuring said control means to said coiled structure.
 2. The leadremoval apparatus of claim 1 wherein said control means comprisesactuator means proximate said distal end of said control means forexpanding said expandable means to said expanded position when saidexpandable means is positioned in said passageway of said coiledstructure.
 3. The lead removal apparatus of claim 2 wherein saidexpandable means includes a relaxed position disengaged from said coiledstructure when said expandable means is positioned in said passageway ofsaid coiled structure.
 4. The lead removal apparatus of claim 1 whereinsaid expandable means includes a slotted sleeve and wherein said controlmeans includes a rod extending through said tube and said slottedsleeve, said slotted sleeve being positioned between a distal end ofsaid tube and a distal end of said rod, said distal ends of said tubeand said rod engaging said slotted sleeve when expanding said slottedsleeve to said expanded position.
 5. The lead removal apparatus of claim4 wherein said distal end of said rod includes a beveled tip.
 6. Thelead removal apparatus of claim 1 wherein said expandable means includesan expandable pliable material sleeve positioned proximate a distal endof said tube.
 7. The lead removal apparatus of claim 6 wherein saidcontrol means further includes a rod extending through said tube andsaid expandable pliable material sleeve.
 8. Lead removal apparatus forremoving an implanted, cardiac lead including a coiled structure havinga passageway extending longitudinally therein, comprising;a tube;control means for moving said coiled structure when secured to saidcoiled structure, said control means slidably arranged in said tube,said control means having a distal end for inserting into saidpassageway of said coiled structure; and expandable means other thansaid tube positioned proximate said distal end of said control means andhaving an expanded position in said passageway of said coiled structurefor securing said control means to said coiled structure; wherein saidexpandable means includes a slotted sleeve, wherein said control meansincludes a rod extending through said tube and said slotted sleeve, saidslotted sleeve being positioned between a distal end of said tube and adistal end of said rod, said distal ends of said tube and said rodengaging said slotted sleeve when expanding said slotted sleeve to saidexpanded position, and wherein said distal end of said outer tube isbeveled.
 9. Extraction device for removing an implanted lead including acoiled structure having a passageway extending longitudinally therein,comprising:a tube; a control means for moving said coiled structure whensaid coiled structure is secured to the control means; said controlmeans comprising a styler being slidably arranged in said tube, saidcontrol means having a distal end that is configured for inserting intosaid passageway of said coiled structure; and an expandable unit, whichis not an integral part of said tube, positioned proximate a distal endof said control means and, when in said passageway of said coiledstructure, for expanding to an expanded position and securing saidcontrol means to said coiled structure.
 10. Device according to claim 9,wherein the expandable unit comprises a spreadable unit being outwardlyspreadable when in said passageway, engaging said coiled structure andsecuring said control means to said lead.
 11. Device for removing a leadimplanted in biological tissue, said lead including a coiled structure(211) having a passageway (210) extending longitudinally therein, saiddevice comprising:a tube (1402; 1502) insertable into said passageway(210) of said coiled structure (211), an actuator means (1403; 1503)extending through said tube (1402; 1502), and an expansible member(1405; 1506) separate from said tube, surrounding said actuator means(1403; 1503) and located before the distal-most end thereof, forestablishing a connecting grip between said actuator means and saidcoiled structure (211) whenever said actuator means (1403; 1503) ismoved relative to said tube (1402; 1502) in a direction towards saidtube (1402; 1502).
 12. Device of claim 11, wherein said tube (1402;1502) has a distal end that is configured to expand the expansiblemember (1405; 1506).
 13. Device for removing a lead implanted inbiological tissue, said lead including a coiled structure (211) having apassageway (210) extending longitudinally therein, said devicecomprising:a tube (1402) having a distal end insertable into saidpassageway (210) of said coiled structure (211), an actuator means(1403) having a distal end and extending through said tube (1402), andan expansible member (1405) separate from said tube and surrounding saidactuator means (1403) and being located before the distal end thereof,for establishing a connecting grip between said actuator means and saidcoiled structure whenever said actuator means (1403) is moved relativeto said tube (1402) in a direction towards said tube (1402), whereinsaid expansible member (1405), when moved along by said distal end ofsaid actuation means (1403) is configured for being pressed onto and forbeing expanded by the distal end of said tube (1402).
 14. Apparatus forremoving a lead (204) with a coiled structure (211) which lead has beenimplanted in biological tissue, said apparatus comprising:a stylet(1403, 1503) configured to be inserted into a longitudinal passageway(210) within the coiled structure; a control tube (1402, 1502) with apassageway (1404, 1504) through which the stylet extends and is movable;and an outwardly expandable unit (1405, 1506) separate from said tubeand configured to be located within the coiled structure for exertinglateral forces on the coiled structure when the stylet is moved relativeto the control tube, whereby the stylet is secured to the coiledstructure to facilitate removal.
 15. The apparatus of claim 14 whereinthe control tube has a distal end that is configured to expand theexpandable unit.